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Last Updated: February 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204209


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NDA 204209 describes ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE, which is a drug marketed by Larken Labs Inc and is included in one NDA. It is available from four suppliers. Additional details are available on the ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE profile page.

The generic ingredient in ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
Pharmacology for NDA: 204209
Mechanism of ActionFull Opioid Agonists
Physiological EffectCentral Nervous System Stimulation
Suppliers and Packaging for NDA: 204209
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE acetaminophen; caffeine; dihydrocodeine bitartrate TABLET;ORAL 204209 ANDA Larken Laboratories Inc. 68047-720 68047-720-01 100 TABLET in 1 BOTTLE (68047-720-01)
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE acetaminophen; caffeine; dihydrocodeine bitartrate TABLET;ORAL 204209 ANDA Skylar Laboratories, LLC 70362-730 70362-730-01 100 TABLET in 1 BOTTLE (70362-730-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;30MG;16MG
Approval Date:Sep 30, 2016TE:RLD:No

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